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Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age

A Multi-center, Randomized, Double-blinded, Phase 3 Trial to Evaluate the Efficacy Against Herpes Zoster of a Live Attenuated Varicella-Zoster Virus Vaccine in Adults Over 40 Years of Age

NCT03314103•Jiangsu Province Centers for Disease Control and Prevention

View on ClinicalTrials.gov

Summary

Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. More than 99.6% of people 40 years of age orolder had evidence of previous VZV infection. This study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine. The investigational vaccines are produced by Changchun Changsheng biotechnology co. LTD. The incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination. And the safety of the varicella-zoster virus vaccine is also evaluated.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Healthy volunteers aged over 40 years (male or female).
•Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
•Able to understand the content of informed consent and willing to sign the informed consent.
•Able to complete the diary card independently.
•For females only (40-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
•Axillary temperature ≤37.0°C.

Exclusion Criteria

•Prior history of herpes zoster.
•Prior history of vaccination with herpes zoster vaccine or chickenpox vaccine.
•History of allergic disease likely to be exacerbated by any component of the vaccine.
•Taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period.
•Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period.
•Participation in another research study involving receipt of an investigational product in the last 30 days.
•Prior administration of attenuated vaccine in last 28 days.
•Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
•History of serious disease and the participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
•Taking immunosuppressive therapy in last 6 months.
+6 more criteria

Locations (3)

Hunan Provincial Center for Disease Control and Prevention

Loudi, Hunan, China

Jiangsu Province Centers for Disease Control and Prevention

Nanjing, Jiangsu, China

Zhejiang Provincial Center for Disease Control and Prevention

Hanzhou, Zhejiang, China

Key Dates

Start Date

October 6, 2017

Primary Completion Date

January 19, 2019

Completion Date

January 19, 2019

Last Updated

March 30, 2021

Enrollment

30,000

ACTUAL participants

Conditions

Herpes Zoster

Interventions

One shot of the varicella-zoster virus vaccine

BIOLOGICAL

one shot of placebo

BIOLOGICAL

The Analgesic Efficacy and Safety of Loxoprofen Sodium Patch in Patients With Herpes Zoster

NCT07378059

Herpes ZosterPain

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RECRUITINGPHASE1/PHASE2

A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

NCT06932523

Herpes Zoster (HZ)

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RECRUITING

A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age

Inclusion Criteria

Exclusion Criteria

The Analgesic Efficacy and Safety of Loxoprofen Sodium Patch in Patients With Herpes Zoster

A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.

Risk Factors of Anxiety and Depression in Patients With Herpes Zoster Neuralgia

Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above

Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above